Evaluating the Effects of Improving Nutritional Intake on Wound Healing in Patients With Diabetic Foot Ulcer
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetic Foot Ulcer
- Sponsor
- Florida State University
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Change in dietary intake of nutrients
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
The overall aim of this study was to assess the effects of nutritional supplementation and education on the healing of foot ulcers in diabetic patients. The hypothesis was that improving dietary intake can promote wound healing by improving nutritional status, blood flow, and decreasing inflammatory biomarkers while increasing anti-inflammatory factors.
Investigators
Raedeh Basiri
Principal Investigator
Florida State University
Eligibility Criteria
Inclusion Criteria
- •male or non-pregnant, non-lactating female ages 50 ± 20 years, diagnosis of diabetes mellitus, undergoing pharmacological treatment for glycemic control, with at least one foot with one ulcer of grade 1A based on University of Texas classification -
Exclusion Criteria
- •Subjects were excluded from the study if they had HbA1c concentrations \> 12%, bioengineered tissue use within four weeks prior to initial screening, a history of radiation treatment to the ulcer site, known immunosuppression, active malignancy, chronic kidney disease, liver failure/cirrhosis, heart failure and/or myocardial infarction in the past three months, use of warfarin, alcohol abuse, or any mental or physiological condition that may interfere with nutrition education and nutritional supplement intake.-
Outcomes
Primary Outcomes
Change in dietary intake of nutrients
Time Frame: 12 weeks
Mean change from baseline in dietary intake of energy(kcal), protein(g), vitamin C(mg), vitamin E(IU), vitamin A(IU), Zinc(mg), Copper(mg), and Manganese(mg) at weeks 4, 8, and 12.
Change in inflammatory biomarkers
Time Frame: 12 weeks
Mean change from baseline in c-reactive protein(ng/ml), interleukin 6(pg/ml), interleukin 10(pg/ml), and tristetraprolin(pg/ml) at weeks 4, 8, and 12
Change in lean body mass and body fat
Time Frame: 12 weeks
Mean change from baseline in lean body mass(lb) and body fat(lb) at weeks 4, 8, and 12
Improvement in wound healing rate(mm^2/week)
Time Frame: 12 weeks
Mean change from baseline in wound area at weeks 4,8, and 12 using the following formula Wound Healing rate= (current area-baseline area)/time (number of weeks)
Secondary Outcomes
- Change in Ankle Brachial Index(ABI)(12 weeks)
- Length of time that a wound achieves complete wound closure(12 weeks)
- Change in basal metabolic rate(12 weeks)